Certain information must be submitted to the TGA for prescription medicine applications to proceed to evaluation.
Before you lodge your application, make sure you read Mandatory requirements for an effective application
Key information for applicants
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PageThis information explains how to submit data in the electronic Common Technical Document (eCTD) format.
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PageThis information explains how to submit data in the Non eCTD electronic Submission (Nees) format.
Guidance and resources
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PageFind out about fees and charges that apply from January 2025
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GuidanceThis guidance explains the administrative and prescribing (dossier) information you need to support the registration or variation of a prescription medicine.
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FormsA list of TGA forms for prescription medicine sponsors.
More information
- Stability testing for prescription medicines
- Guidance 18: Impurities in drug substances and drug products
- Guidance 11: Drug Master Files and Certificates of Suitability of a Monograph of the European Pharmacopoeia for drug substances
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Bioavailability, bioequivalence and biowaiver data summary forms
Dossier requirements
- General dossier requirements
- Dossier documents matrix: Module 1
- Dossier documents matrix: Module 2-5
- Submission dossier checklist for prescription medicines
Common technical document
Electronic submissions
- Australian electronic submission basics
- Electronic submissions
- AU eCTD specification: Module 1 and regional information
- eCTD AU module 1 and regional information
- Automation of validation of eCTD and NeeS sequences
Orphan designations
Priority Determinations
Provisional determinations
Minor Variations (includes Cat 3, SAR, SRR, MEC, EOI Generics, 9D(2C) Notifications
Additional Trade Name Applications
Section 14 exemption requests
Topics